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510(k) K192322

T-Stat 2.0 Microvascular Tissue Oximeter by Spectros Corporation — Product Code MUD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 23, 2019
Date Received
August 27, 2019
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Oximeter, Tissue Saturation
Device Class
Class II
Regulation Number
870.2700
Review Panel
SU
Submission Type

Other clearances by Spectros Corporation

  • K081233 — T-STAT 303 ISCHEMIA MONITORING SYSTEM (July 28, 2008)
  • K040684 — T-STAT MICROVASCULAR TISSUE OXIMETER, MODEL 303 (November 5, 2004)

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  • K223651 — Cerebral Adaptive Index (CAI) Algorithm (May 26, 2023)
  • K214072 — Masimo O3 Regional Oximeter System (May 6, 2022)